FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.
An Ars Technica post says FDA has dropped a Web page that listed some specific bogus autism treatments and therapies and warned of their potential hea...
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agencys abil...
FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubruti...
FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could r...
